GlaxoSmithKline

Job Title: Principal Lead, Data Standards

Business Introduction

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.

Find out more:

Our approach to R&D

Position Summary

The Principal Lead, Data Standards will lead and/or support cross-functional teams in maintaining and enhancing global analysis and reporting data standards, ensuring innovation, compliance, and alignment with Standard Governance. As a key Subject Matter Expert in analysis & reporting standards such as CDISC ADaM, this role will contribute to the development of high-quality data standards, provide guidance to team members, and may include product ownership responsibilities for specific standards or tools.. Additionally, this position provides mentorship and supervision to team members.

In this role you will…

Analysis and Reporting Standards Development and Management

• Develop, manage, and optimize GSK-specific data standards, aligning with industry benchmarks (e.g., CDISC), regulatory and scientific requirements to define custom standards, and creating supporting documentation in response to business needs.

Cross-Functional Collaboration

• Coordinate and contribute to cross-functional teams across R&D functions (e.g. Clinical, Medical, Programming, Statistics, Data Management, Medical Writing, Regulatory and Safety) to establish core and therapeutic area standards and promote effective teamwork.

Compliance and Risk Management

• Ensure adherence to industry and regulatory data standards mandates, assess proposals and regulatory changes, conduct risk analysis, and implement necessary updates and corrective actions in response to audits for global data standards.

Process and Stakeholder Optimization

• Contribute to the development and maintenance of process documents (SOPs, templates, best practices) and work with stakeholders to improve processes and technologies related to data standards maintenance and adoption.

Product Ownership

• Serve as a product owner for specific data standards or tools, such as ADaM standards.
• Oversee the lifecycle management of assigned products, ensuring they meet business needs and align with regulatory and scientific requirements.
• Collaborate with stakeholders to prioritize product updates and enhancements.

Leadership and Oversight

• Represent the organization in internal and external initiatives (e.g., CDISC, PhUSE), manage matrix teams, and support talent development through coaching, mentoring, appraisals, and workload management. May also oversee and guide some activities delivered by our CRO partners.

Advocacy and Consultancy

• Act as a champion for data standards across the organization, supporting stakeholder awareness, providing consultancy on data standards (core and therapeutic), and serving on cross-functional/external boards or project teams as needed.

Basic Qualifications & Skills:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor’s degree in sciences, or equivalent functional industry experience, in Life Sciences, Computer Sciences, Mathematics and Physics or equivalent.
• Proven experience over approximately 5+ years working in pharmaceutical industry/Clinical Trial, Clinical Programming with expertise in industry data standards (e.g., CDISC) and deep understanding of analysis and reporting requirements for clinical trials.
• Proven ability to analyse business problems/opportunities within at least one of the data stewardship areas (e.g., asset management, data standards, life cycle management and provision of assets).
• Track record of developing and delivering high quality solutions / deliverables.
• Proven ability to clearly convey information orally and in writing (technical documentation, presentations to business stakeholders, etc.) to audiences with varied and sometimes limited technical knowledge.
• Excellent record of customer focus, influence, delivery, innovation, follow through and acting as a catalyst for change.

Preferred Qualifications & Skills:

• Master’s Degree in Sciences, or equivalent functional industry experience, in Life Sciences, Computer Sciences, Mathematics and Physics or equivalent.
• Programming or data science experience is preferable.
• Experience mentoring, coaching and/or guiding matrix teams working on analysis and reporting standards.
• Experience of agile project management.

We encourage you to apply if you are excited about this opportunity and meet the qualifications. Join us in making a meaningful impact and advancing your career at GSK!

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

Inclusion at GSK:

As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process.

Please contact our Recruitment Team at IN.recruitment-adjustments@gsk.com to discuss your needs.

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